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Experimental device aims to tackle medical condition

NCT ID NCT07711093

Disease control Sponsor: Boston Scientific Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 17, 2026 · Last updated Sep 18, 2026 · Updated 7 times

Summary

This trial investigates a device that has not been approved by the U.S. FDA. It enrolls participants with a specific medical condition to see if the device is safe and works as intended. The study will compare outcomes in those who receive the device versus those who do not.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an unapproved medical device
What this could lead to
If successful, this device could offer a new treatment option for the condition being studied.
What could go wrong
The device is not yet approved, and its safety and effectiveness are unproven. Early trials may not show benefit or could reveal unexpected risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 74 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria 1. Confirmed Type II anastomotic leaks in the esophagus or stomach * Type I: Leak requiring no change in treatment * Type II: Leak requiring intervention but not surgery * Type III: Leak requiring surgical intervention 2. Subject has an anastomotic leak in the esophagus or stomach that is endoscopically accessible within the range of the overtube length. 3. Subject is eligible for endoscopic intervention. 4. Subject has a transmural defect of at least 2 cm in diameter in the esophagus or stomach. 5. Subject understands the trial requirements and is willing and able to comply with the study procedures, all protocol-required follow up evaluations and provide written informed consent to participate in the study. 6. Investigator decision that EVT is the most suitable treatment of the available treatment options. Exclusion Criteria: 1. Subject is under 18 years of age. 2. Potentially vulnerable subject, including, but not limited to pregnant women. 3. Subject has undergone EVT or other similar interventions for the current leak. 4. Subject had upper gastrointestinal surgery resulting in the leak more than 60 days prior to the planned study procedure. 5. Subject has any necrotic tissue that would require endoscopic debridement prior to Eso-SPONGETM placement. 6. Subject has known contraindication for EVT as per the Investigator Brochure (IB) 7. Subject is currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor.

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Conditions

The condition(s) this trial relates to.

Anastomotic Leak

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anastomotic leaks

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Baylor University Medical Center

    Dallas, Texas, 76246, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.